Patent reform could be the next big move to help bring down drug prices
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After pitched battles over Medicare drug price negotiations, Congress may be pivoting to more bipartisan ground: overhaul of the patent system that allows brand-name drugs to delay competition for years.
Why it matters: There's widespread agreement that pharmaceutical companies have gamed the system through tactics like "product hopping," where a drug company makes small changes to a drug in a bid to keep cheaper generics from reaching the market sooner.
State of play: Congress over the years has taken multiple stabs at policy changes lawmakers say would increase competition and drive down prices.
- However, a legislative package of patent reforms has been stuck in the Senate for 15 months, raising questions about whether leadership will try to pass anything before the elections.
- Drugmakers are pushing back against these bills, arguing that 90% of prescriptions at pharmacy counters already are filled with generics and biosimilars — and that pharmacy benefit managers and pharmacies they work with are the real culprits behind price increases.
The big picture: The more drug prices rise, the more attention is focused on the way drugmakers can delay competition.
- The maneuvering around AbbVie's blockbuster Humira, which until recently had a 20-year $200 billion monopoly, was one of the catalysts for change.
- A bipartisan plan from Sens. John Cornyn (R-Texas) and Richard Blumenthal (D-Conn.) took steps to address product hopping and placed a limit on the number of patents a company can contest, to crack down on "patent thickets" that delay competition.
- But that bill has been parked awaiting floor action since the Senate Judiciary Committee advanced it in February 2023.
- "We pass all these bills. We have a common view of the problem and nothing ever happens," Judiciary Ranking Member Lindsey Graham (R-S.C.) vented at a hearing on drug competition Tuesday.
Meanwhile, Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.) are pushing a pair of bills they say are essential to overhauling the patent process but that critics contend could wind up helping the pharmaceutical industry.
- Both lawmakers, whose states are home to big drugmakers, were top recipients of campaign contributions from pharma interests.
- One bill, the PREVAIL Act, would limit who can challenge patents only to those with legal standing, either by having been sued or threatened with a patent infringement lawsuit.
- The second bill, the PERA Act, essentially would amend the law to change which inventions are eligible for patent protection and make it easier for certain scientific discoveries to be patented.
- Chris Bruno, a life sciences patent lawyer at McDermott Will and Emery, said that could cover modified genes or discoveries "that require a lot of research and have finance and expectation behind them."
Friction point: Advocacy groups like Families USA and Patients for Affordable Drugs have spoken out against the PREVAIL Act and urged lawmakers to protect the current system, noting how the bill could make drug prices higher, in part by making it harder to cancel invalid patents.
What we're watching: Whether Senate Majority Leader Chuck Schumer (D-N.Y.) makes floor time for the overhaul — and whether the policy changes can catch a ride on an expected year-end health deal.
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